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NCT01987492 · ClinicalTrials.gov registry record · Phase 2
A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 230
- Enrollment target
NCT01987492: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT01987492 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 230 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01987492, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 230 participants
- Enrollment target
Study Summary
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed. Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment. Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.
Interventions
- DRUG Placebo
- DRUG Lebrikizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2014-02-28 |
| Est. Completion | 2016-12-20 |
| Phase | Phase 2 |
What the finished NCT01987492 record still lists
NCT01987492 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01987492 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01987492 about?
NCT01987492 is a clinical study titled "A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma". This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/p...
What is the current status of trial NCT01987492?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 230 participants. The study started on 2014-02-28. Estimated completion is 2016-12-20.
What interventions are being tested in trial NCT01987492?
The interventions under investigation include: Placebo (DRUG), Lebrikizumab (DRUG).
Who is sponsoring clinical trial NCT01987492?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01987492's enrollment target sits among peer trials
230 257th of 2000 higher than 1,737 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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